Purpose

The purpose of this two-part Phase 2 study is to assess the safety, tolerability and efficacy of aerosolized SF-RI 1 (AeroFact) when delivered via nCPAP at two different doses.

Condition

Eligibility

Eligible Ages
Between 26 Weeks and 31 Weeks
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Parental consent obtained prior to study procedures being performed (pre-natal consent is allowed) 2. 26 0/7 to 30 6/7 weeks of gestational age 3. Weight <2.0 Kg 4. Respiratory Severity Score (RSS) > 1.5

Exclusion Criteria

  1. Apgar score less than or equal to 5 at five minutes after birth 2. Need for chest compressions or administration of epinephrine or bicarbonate in the delivery room 3. Premature rupture of membranes (PROM) > 7 days, or known sepsis with PROM prior to 7 days 4. Need for intubation and/or mechanical ventilation prior to enrollment 5. Active pneumothorax requiring chest tube 6. Significant congenital anomaly, chromosomal abnormality 7. Concomitant treatments with inhaled nitric oxide

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Partially Blinded, Randomized, Parallel-Group Dose Ranging
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Masking within active arms

Arm Groups

ArmDescriptionAssigned Intervention
Other
nCPAP alone
Standard of Care (nasal continuous positive airway pressure-nCPAP) with instilled bolus surfactant when medically necessary
  • Other: nCPAP
    nCPAP (nasal continuous positive airway pressure) alone
Experimental
Drug: Low Dose AeroFact
AeroFact-low dose SF-RI 1
  • Drug: AeroFact
    Aerosolized SF-RI 1
    Other names:
    • SF-RI 1
Experimental
Drug: High Dose AeroFact
AeroFact-high dose SF-RI 1
  • Drug: AeroFact
    Aerosolized SF-RI 1
    Other names:
    • SF-RI 1

Recruiting Locations

University of Virginia
Charlottesville, Virginia 22947
Contact:
Monika Thielen

More Details

NCT ID
NCT03969992
Status
Recruiting
Sponsor
Aerogen Pharma Limited

Study Contact

Judy Doto, RN, BSN
484-716-5438
judydoto@aerogenpharma.com

Detailed Description

Part I Primary Objective To determine an optimal dose of AeroFact administered by nasal continuous positive airway pressure (nCPAP) versus stand of care in reducing the rate of intubation/cannulation and bolus surfactant instillation in the first 7 days after birth. Part II Primary Objective To evaluate pulmonary outcomes and respiratory utilization at 3, 6, 9, and 12 months post-menstrual age (PMA)

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.